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| Product NDC Code | 57782-397 | ||||
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| Drug Name | Cromolyn sodium |
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| Type | Generic | ||||
| Pharm Class | Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY, METERED | ||||
| RxCUI drug identifier | 1797851 | ||||
| Application Number | ANDA075702 | ||||
| Labeler Name | Bausch & Lomb Incorporated | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per spray) Cromolyn sodium 5.2 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • see package insert on how to use pump • parent or care provider must supervise the use of this product by young children • adults and children 2 years and older: • spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day. • use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust) • to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact. • if desired, you can use this product with other medicines, including other allergy medicines. • children under 2 years: Do not use unless directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, edetate disodium, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose
Purpose
Information about the drug product’s indications for use.Purpose Nasal allergy symptom controller
Spl product data elements
Usually a list of ingredients in a drug product.Cromolyn Sodium Cromolyn Sodium CROMOLYN SODIUM CROMOLYN BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel HealthGuard NDC 57782-397-26 Cromolyn Sodium Nasal Solution, USP NASAL SPRAY Nasal Allergy Symptom Controller For intranasal use only. Prevents and Relieves Nasal Allergy Symptoms: • runny/itchy nose • sneezing • allergic stuffy nose Original Prescription Strength Safe For Ages 2+ 200 Metered Sprays Each spray delivers 5.2 mg cromolyn sodium 0.88 FL OZ (26 mL) carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.( Adults and children 2 years and older )
Other information • store between 20-25°C (68-77°F) • protect from light • keep carton and package insert. They contain important instructions. • see bottom panel for lot number and expiration date
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have • fever • discolored nasal discharge • sinus pain • wheezing
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • if you are allergic to any of the ingredients
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll-free 1-800-323-0000
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • shortness of breath, wheezing, or chest tightness occurs • hives or swelling of the mouth or throat occurs • your symptoms worsen • you have new symptoms • your symptoms do not begin to improve within two weeks • you need to use for more than 12 weeks
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks. • brief stinging or sneezing may occur right after use • do not use it to treat sinus infection, asthma, or cold symptoms • do not share this bottle with anyone else as this may spread germs
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Do not use • if you are allergic to any of the ingredients Ask a doctor before use if you have • fever • discolored nasal discharge • sinus pain • wheezing When using this product • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks. • brief stinging or sneezing may occur right after use • do not use it to treat sinus infection, asthma, or cold symptoms • do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if • shortness of breath, wheezing, or chest tightness occurs • hives or swelling of the mouth or throat occurs • your symptoms worsen • you have new symptoms • your symptoms do not begin to improve within two weeks • you need to use for more than 12 weeks If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API